BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 19936165 · Received August 8, 2024

    Report

    Report Number
    1625507-2024-00260
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 15, 2024
    Report Date
    October 9, 2024
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    UDI-DI
    00613994933706
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: IT WAS FOUND IN THE ANALYSIS THAT THE BEARINGS WERE WORN LASER MARKINGS WERE FADED AND SPRING WAS WORN. H6: FDM B21, FDR C21, IMG G04130 AND FDC D16 CODES NO LONGER APPLY. PRODUCT MODEL NUMBER: 1845020, PRODUCT DESCRIPTION: ATTACHMENT 1845020 INDIGO OTOL ANGLED, SERIAL/LOT NUMBER: P06245364/210474943 - IT WAS FOUND IN THE ANALYSIS THAT THE DISTAL BEARING WAS DETACHED. THE LASER MARKINGS WERE FADED. H6:FDM B01, FDR C0601, C07 IMG G04011,G02004,G04118 AND FDC D02 PRODUCT MODEL NUMBER: 1845000, PRODUCT DESCRIPTION: DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC, SERIAL/LOT NUMBER : 13I3045/208048681 - IT WAS FOUND IN THE ANALYSIS THAT THE BEARING AND SPRING WERE WORN. THE LASER MARKINGS WERE FADED. H6:FDM B01, FDR C0601, C070602 IMG G04011,G04080 AND FDC D02 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT MODEL NUMBER: 1845020, PRODUCT DESCRIPTION: ATTACHMENT 1845020 INDIGO OTOL ANGLED, SERIAL/LOT NUMBER: (B)(6)/210474943, UDI#: (B)(4), PRODUCT MODEL NUMBER: 1845000, PRODUCT DESCRIPTION: DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC, SERIAL/LOT NUMBER: (B)(6)/208048681, UBD: , UDI#: (B)(4). ANNEX G CODE FOR ANGLED INDIGO ATTACHMENT IS G04130. ANNEX G CODE FOR INDIGO HANDPIECE IS G04063. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE INDIGO ATTACHMENT WAS NOT HELD SECURELY AND WAS VIBRATING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326879 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS 1845010 212016152 00613994933706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown "SEE H11....".